Description

Carbetocin Acetate is a synthetic, long-acting oxytocin receptor agonist and peptide-based uterotonic agent widely used in obstetric and pharmaceutical research settings. It offers enhanced stability and prolonged pharmacodynamic activity compared to native oxytocin, making it critical for reliable postpartum hemorrhage (PPH) prophylaxis and controlled uterine contraction studies. This compound is essential for pharmaceutical manufacturers developing sterile injectables, clinical trial material suppliers, and contract development and manufacturing organizations (CDMOs) supporting global regulatory submissions. Carbetocin Acetate CAS NO 1631754-28-3 is supplied as a high-purity, analytically characterized active pharmaceutical ingredient (API) meeting stringent international quality benchmarks.

Application

• Active pharmaceutical ingredient (API) for sterile lyophilized injection formulations targeting postpartum hemorrhage prevention
• Reference standard in pharmacokinetic and pharmacodynamic studies of uterotonic agents
• Key intermediate in the synthesis and stability testing of next-generation oxytocin analogues
• Controlled substance in preclinical reproductive toxicology and dose-response modeling
• Calibration standard for HPLC, UPLC, and LC-MS/MS analytical method validation in GMP-compliant QC laboratories
• Research tool for investigating oxytocin receptor binding kinetics and signal transduction pathways
• Component in formulation development of heat-stable, room-temperature-storable uterotonic products
• Quality control reference for biosimilar and generic carbetocin product registration dossiers (FDA, EMA, PMDA, WHO prequalification)

Basic Information

Product Name	Carbetocin Acetate
CAS No.	1631754-28-3
Molecular Formula	C45H69N13O12·C2H4O2
Molecular Weight	1064.15 g/mol (acetate salt)
Synonyms	Carbetocin acetate; 1-Deamino-1-[O-(tetrahydro-2-furanyl)]-carba-(1-carboxy-2-methylpropyl)-oxytocin acetate; [1-Deamino, 1-O-(tetrahydrofurfuryl), 2-(O-methyl)-tyrosine]-oxytocin acetate; Carbetocin hemi-acetate; CBTC-Ac; NSC-671930; UNII-2N7JQ7W4ZB; CAS 1631754-28-3; Oxytocin, 1-deamino-1-[O-(tetrahydro-2-furanyl)]-carba-(1-carboxy-2-methylpropyl)-, acetate
EINECS	Contact for details

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request. All batches conform to ICH Q5, Q7, and Q8 guidelines, and are manufactured under cGMP conditions compliant with FDA 21 CFR Part 211 and EU Annex 1. Testing includes full identity confirmation (IR, NMR, MS, amino acid analysis), assay quantification (HPLC with UV detection), and impurity profiling (related substances by gradient HPLC, residual solvents by GC). Sterility and endotoxin testing are performed for API-grade material intended for parenteral use.

Storage

Preserve in a tightly closed container, protected from light. Store at 2–8 °C under inert atmosphere (nitrogen or argon) to prevent degradation. Due to its hygroscopic nature, maintain low humidity (<30% RH) and avoid repeated exposure to ambient air. Handle under controlled temperature and humidity conditions during dispensing.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0–102.0%
Related Substances (HPLC)	≤ 2.0% total impurities; individual impurity ≤ 0.5%
Residual Solvents (GC)	Meets ICH Q3C limits (e.g., acetonitrile ≤ 410 ppm, methanol ≤ 3000 ppm)
Water (KF)	≤ 8.0%
Heavy Metals	≤ 20 ppm
Bacterial Endotoxins	≤ 1.0 EU/mg
Sterility	Complies with USP <71>

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.